The present application relates generally to the storage of medical records with electronic signatures.
An electronic record is used to store information in digital format. The format of the record may vary from system to system. There are number of advantages of electronic over printed records, especially when applied to medical devices, including: accuracy of information, flexibility of storage in terms of physical space, effectively instantaneous availability to access and easiness of transfer between different homogenous and heterogeneous systems.
In addition, electronic records offer the possibility to be electronically signed off to make them equivalent to conventionally signed paper records. Electronic signatures have a variety of formats including biometrics (e.g. fingerprints) and a combination of at least two identifications (e.g. a pair of user name and password). Electronic signatures can be used to acknowledge approval of electronic records.
In the medical devices field, electronic records and electronic signatures are regulated by corresponding regulatory bodies for specific geographic regions of the globe. High level requirements of electronic records and electronic signatures can include the following: (1) safe and secure long term storage of records; (2) accessibility of stored records to regulatory audits upon request; (3) assurance of data integrity between source and storage of the record; and (4) security of access to stored data. Systems intending to claim compliance with regulations of electronic records and electronic signatures are directed to satisfying one or more of these requirements.